ECSP088485A - SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACO - Google Patents
SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACOInfo
- Publication number
- ECSP088485A ECSP088485A EC2008008485A ECSP088485A ECSP088485A EC SP088485 A ECSP088485 A EC SP088485A EC 2008008485 A EC2008008485 A EC 2008008485A EC SP088485 A ECSP088485 A EC SP088485A EC SP088485 A ECSP088485 A EC SP088485A
- Authority
- EC
- Ecuador
- Prior art keywords
- injection
- prevent
- reconstitution
- dilution
- sodium chloride
- Prior art date
Links
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 title abstract 4
- 239000000243 solution Substances 0.000 title abstract 4
- 239000012895 dilution Substances 0.000 title abstract 2
- 238000010790 dilution Methods 0.000 title abstract 2
- 239000011780 sodium chloride Substances 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 6
- 238000002347 injection Methods 0.000 abstract 5
- 239000007924 injection Substances 0.000 abstract 5
- 206010018910 Haemolysis Diseases 0.000 abstract 3
- 230000004520 agglutination Effects 0.000 abstract 3
- 210000004027 cell Anatomy 0.000 abstract 3
- 230000008602 contraction Effects 0.000 abstract 3
- 230000008588 hemolysis Effects 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 3
- 230000018044 dehydration Effects 0.000 abstract 1
- 238000006297 dehydration reaction Methods 0.000 abstract 1
- 210000003743 erythrocyte Anatomy 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La invención proporciona métodos para la preparación de formulaciones farmacéuticas para inyección tal que en la inyección la formulación no provoque la aglutinación de eritrocitos, hemólisis, y/o contracción de células. Para prevenir la aglutinación, una formulación farmacéutica preparada para inyección necesita tener una fuerza iónica suficiente. Para prevenir la hemólisis o la contracción de células, una formulación farmacéutica preparada para inyección necesita ser casi isotónica con respecto al plasma. La invención proporciona métodos que preparan formulaciones farmacéuticas para inyección que tienen tanto la fuerza iónica suficiente para prevenir la aglutinación y la tonicidad requerida para prevenir hemólisis o deshidratación o contracción de células significativas. Los métodos presentes involucran el uso de soluciones de cloruro de sodio que son alrededor de 25 MM hasta alrededor de 150 mM para reconstitución de tortas liofilizadas (u otras formulaciones farmacéuticas no líquidas) en solución o para dilución de soluciones de formulación farmacéutica.The invention provides methods for the preparation of pharmaceutical formulations for injection such that in the injection the formulation does not cause erythrocyte agglutination, hemolysis, and / or cell contraction. To prevent agglutination, a pharmaceutical formulation prepared for injection needs to have sufficient ionic strength. To prevent hemolysis or cell contraction, a pharmaceutical formulation prepared for injection needs to be almost isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both sufficient ionic strength to prevent agglutination and tonicity required to prevent hemolysis or dehydration or contraction of significant cells. The present methods involve the use of sodium chloride solutions that are about 25 MM to about 150 mM for reconstitution of lyophilized cakes (or other non-liquid pharmaceutical formulations) in solution or for dilution of pharmaceutical formulation solutions.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US73222105P | 2005-11-01 | 2005-11-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP088485A true ECSP088485A (en) | 2008-06-30 |
Family
ID=37801586
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EC2008008485A ECSP088485A (en) | 2005-11-01 | 2008-05-30 | SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACO |
Country Status (31)
| Country | Link |
|---|---|
| US (4) | US20070135343A1 (en) |
| EP (3) | EP3225233B1 (en) |
| JP (1) | JP5555425B2 (en) |
| KR (2) | KR20110128957A (en) |
| CN (1) | CN101351190B (en) |
| AR (2) | AR056748A1 (en) |
| AU (1) | AU2006308921C1 (en) |
| BR (1) | BRPI0618133A2 (en) |
| CA (1) | CA2626531C (en) |
| CR (1) | CR9958A (en) |
| DK (2) | DK3225233T3 (en) |
| EC (1) | ECSP088485A (en) |
| ES (2) | ES2749574T3 (en) |
| FI (1) | FI1942868T4 (en) |
| FR (1) | FR20C1005I1 (en) |
| GT (1) | GT200800037A (en) |
| HK (1) | HK1245090B (en) |
| HU (4) | HUE045421T2 (en) |
| IL (1) | IL190843A (en) |
| LU (1) | LUC00035I2 (en) |
| MY (1) | MY184364A (en) |
| NO (1) | NO347263B1 (en) |
| NZ (1) | NZ567685A (en) |
| PE (3) | PE20070714A1 (en) |
| PL (2) | PL1942868T5 (en) |
| PT (2) | PT1942868T (en) |
| RU (1) | RU2432157C2 (en) |
| SI (2) | SI1942868T2 (en) |
| TW (1) | TWI480063B (en) |
| UA (1) | UA97234C2 (en) |
| WO (1) | WO2007053533A2 (en) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA97234C2 (en) | 2005-11-01 | 2012-01-25 | Уайєт | Sodium chloride solution for reconstituting lyophilized factor ix formulation |
| US7833527B2 (en) | 2006-10-02 | 2010-11-16 | Amgen Inc. | Methods of treating psoriasis using IL-17 Receptor A antibodies |
| US8431011B2 (en) * | 2008-01-31 | 2013-04-30 | Abbott Diabetes Care Inc. | Method for automatically and rapidly distinguishing between control and sample solutions in a biosensor strip |
| KR101614983B1 (en) * | 2009-11-17 | 2016-04-22 | 입센 파마 에스.에이.에스 | Formulation for hgh and rhigf-1 combination |
| US10634741B2 (en) | 2009-12-04 | 2020-04-28 | Endomagnetics Ltd. | Magnetic probe apparatus |
| US9427186B2 (en) | 2009-12-04 | 2016-08-30 | Endomagnetics Ltd. | Magnetic probe apparatus |
| EA031209B9 (en) | 2010-01-15 | 2021-11-19 | Кирин-Эмджен, Инк. | Antibody pharmaceutical formulation for treating an inflammatory disease and methods of using same |
| BR112012022223B1 (en) * | 2010-03-01 | 2022-08-09 | Cytodyn Inc | CONCENTRATED PROTEIN FORMULATION, USE AND METHOD OF PREPARING IT |
| SG10201913700SA (en) | 2010-07-09 | 2020-03-30 | Bioverativ Therapeutics Inc | Factor ix polypeptides and methods of use thereof |
| HK1213521A1 (en) * | 2012-09-25 | 2016-07-08 | Bioverativ Therapeutics Inc. | Methods of using fix polypeptides |
| CN105283202B (en) | 2013-03-11 | 2019-04-23 | 安都磁学有限公司 | Hypotonic solution for lymph node detection |
| US9234877B2 (en) | 2013-03-13 | 2016-01-12 | Endomagnetics Ltd. | Magnetic detector |
| US9239314B2 (en) | 2013-03-13 | 2016-01-19 | Endomagnetics Ltd. | Magnetic detector |
| EA037906B1 (en) * | 2013-03-15 | 2021-06-04 | Биовератив Терапьютикс Инк. | Factor ix polypeptide formulations |
| FR3005420B1 (en) | 2013-05-07 | 2015-09-18 | Erytech Pharma | METHOD OF STABILIZING SUSPENSIONS OF ERYTHROCYTES ENCAPSULATING AN ACTIVE INGREDIENT, SUSPENSIONS OBTAINED |
| EP3123090A4 (en) * | 2014-03-24 | 2017-12-13 | Bioverativ Therapeutics Inc. | Lyophilized factor ix formulations |
| US9351945B1 (en) * | 2015-02-27 | 2016-05-31 | John Daniel Dobak, III | Reduction of adipose tissue |
| GB2536703B (en) * | 2015-03-27 | 2020-12-02 | Ge Healthcare Bio Sciences Ab | Method for baseline correction in a chromatogram |
| EP3081942A1 (en) * | 2015-04-17 | 2016-10-19 | Roche Diagniostics GmbH | Pressure transmission liquid for cellular analyzer, cellular analyzer and method for analyzing a liquid cellular sample |
| EP3782575A1 (en) | 2015-06-04 | 2021-02-24 | Endomagnetics Ltd. | Marker materials and forms for magnetic marker localization (mml) |
| US10124021B2 (en) * | 2016-12-23 | 2018-11-13 | Andrew L. Gostine | Intravenous fluid |
| JP7110360B2 (en) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | Freeze-drying method |
| JP7541993B2 (en) | 2019-03-14 | 2024-08-29 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | Freeze-drying loading tray assembly, freeze-drying system and freeze-drying method |
| US12036187B2 (en) * | 2019-05-01 | 2024-07-16 | Southwest Research Institute | Compositions of dimethyl trisulfide (DMTS) as a cyanide antidote |
| US20220387416A1 (en) * | 2019-10-25 | 2022-12-08 | Cmc Pharmaceuticals, Inc. | Atropine-scopolamine with enhanced stability |
| IL272145A (en) | 2020-01-20 | 2021-07-29 | Stem Cell Medicine Ltd | Cosmetic preparations with protein concentrate from a conditioned growth medium of stem cells from adipose tissue |
| US12274450B2 (en) * | 2020-08-03 | 2025-04-15 | Transluminal Systems, Llc | Devices and methods for trans-arterial osmotic embolization of pathological tissue |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3717708A (en) * | 1968-10-24 | 1973-02-20 | Cutter Lab | Blood coagulation complex |
| US4364861A (en) | 1980-05-27 | 1982-12-21 | Cutter Laboratories, Inc. | Blood-coagulation-promoting products and methods of preparing them |
| US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| PT2193809E (en) | 1999-02-22 | 2015-08-24 | Baxter Int | Albumin-free factor viii formulations |
| US20010031721A1 (en) * | 1999-05-05 | 2001-10-18 | Chandra Webb | Highly concentrated, lyophilized, and liquid factor IX formulations |
| PT1324776E (en) * | 2000-10-12 | 2009-12-23 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| ES2676644T3 (en) * | 2003-12-19 | 2018-07-23 | Novo Nordisk Health Care Ag | Stabilized compositions of factor VII polypeptides |
| EP1720519A1 (en) * | 2004-03-04 | 2006-11-15 | Wyeth | Lyophilization method to improve excipient crystallization |
| UA97234C2 (en) | 2005-11-01 | 2012-01-25 | Уайєт | Sodium chloride solution for reconstituting lyophilized factor ix formulation |
-
2006
- 2006-10-27 UA UAA200807432A patent/UA97234C2/en unknown
- 2006-10-27 ES ES17166616T patent/ES2749574T3/en active Active
- 2006-10-27 JP JP2008538945A patent/JP5555425B2/en active Active
- 2006-10-27 KR KR1020117027131A patent/KR20110128957A/en not_active Withdrawn
- 2006-10-27 PT PT68270362T patent/PT1942868T/en unknown
- 2006-10-27 US US11/589,002 patent/US20070135343A1/en not_active Abandoned
- 2006-10-27 PE PE2006001318A patent/PE20070714A1/en not_active Application Discontinuation
- 2006-10-27 NZ NZ567685A patent/NZ567685A/en unknown
- 2006-10-27 RU RU2008119514/15A patent/RU2432157C2/en active
- 2006-10-27 DK DK17166616.7T patent/DK3225233T3/en active
- 2006-10-27 ES ES06827036T patent/ES2627684T5/en active Active
- 2006-10-27 CN CN2006800400807A patent/CN101351190B/en active Active
- 2006-10-27 PT PT171666167T patent/PT3225233T/en unknown
- 2006-10-27 SI SI200632172T patent/SI1942868T2/en unknown
- 2006-10-27 NO NO20082180A patent/NO347263B1/en unknown
- 2006-10-27 PL PL06827036.2T patent/PL1942868T5/en unknown
- 2006-10-27 HU HUE17166616A patent/HUE045421T2/en unknown
- 2006-10-27 AU AU2006308921A patent/AU2006308921C1/en active Active
- 2006-10-27 PE PE2011000653A patent/PE20110803A1/en not_active Application Discontinuation
- 2006-10-27 WO PCT/US2006/042258 patent/WO2007053533A2/en not_active Ceased
- 2006-10-27 PE PE2015001729A patent/PE20151284A1/en not_active Application Discontinuation
- 2006-10-27 DK DK06827036.2T patent/DK1942868T5/en active
- 2006-10-27 EP EP17166616.7A patent/EP3225233B1/en not_active Revoked
- 2006-10-27 BR BRPI0618133-3A patent/BRPI0618133A2/en not_active Application Discontinuation
- 2006-10-27 EP EP19189599.4A patent/EP3593790A1/en not_active Withdrawn
- 2006-10-27 HU HUE06827036A patent/HUE033949T2/en unknown
- 2006-10-27 PL PL17166616T patent/PL3225233T3/en unknown
- 2006-10-27 SI SI200632348T patent/SI3225233T1/en unknown
- 2006-10-27 KR KR1020087013252A patent/KR101126670B1/en active Active
- 2006-10-27 TW TW095139724A patent/TWI480063B/en active
- 2006-10-27 CA CA2626531A patent/CA2626531C/en active Active
- 2006-10-27 MY MYPI20081347A patent/MY184364A/en unknown
- 2006-10-27 EP EP06827036.2A patent/EP1942868B2/en active Active
- 2006-10-31 AR ARP060104769A patent/AR056748A1/en not_active Application Discontinuation
-
2008
- 2008-04-14 IL IL190843A patent/IL190843A/en active IP Right Grant
- 2008-04-17 GT GT200800037A patent/GT200800037A/en unknown
- 2008-05-07 CR CR9958A patent/CR9958A/en not_active Application Discontinuation
- 2008-05-30 EC EC2008008485A patent/ECSP088485A/en unknown
-
2016
- 2016-10-07 US US15/288,860 patent/US20170021022A1/en not_active Abandoned
-
2017
- 2017-09-25 LU LU00035C patent/LUC00035I2/fr unknown
- 2017-09-27 HU HUS1700035C patent/HUS1700035I1/en unknown
-
2018
- 2018-04-04 HK HK18104477.4A patent/HK1245090B/en unknown
- 2018-07-06 AR ARP180101902 patent/AR112443A2/en not_active Application Discontinuation
-
2019
- 2019-12-20 US US16/723,563 patent/US20200138952A1/en not_active Abandoned
-
2020
- 2020-01-31 HU HUS2000003C patent/HUS2000003I1/en unknown
- 2020-02-10 FR FR20C1005C patent/FR20C1005I1/en active Active
- 2020-07-14 US US16/946,998 patent/US20200338199A1/en not_active Abandoned
-
2023
- 2023-03-17 FI FIEP06827036.2T patent/FI1942868T4/en active
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